Companion Diagnostic Test for CRC Patients Identifies Eligible Treatment Population

Colorectal cancer remains one of the leading causes of cancer-related deaths worldwide, and identifying which patients will benefit most from targeted immunotherapies is critical. Existing diagnostic methods can be time-consuming, complex, and limit timely treatment access. Now, a newly approved fully automated diagnostic test enables rapid detection of patients with microsatellite instability-high (MSI-H) colorectal cancer, helping to guide precision therapy choices.

The Idylla CDx MSI Test, developed by Biocartis (Mechelen, Belgium) in collaboration with Bristol Myers Squibb (Princeton, NJ, USA), qualitatively detects a panel of seven MSI biomarkers in colorectal cancer tissue samples. Designed for use on the Idylla Platform, the test requires less than three minutes of hands-on time and delivers results in under three hours through a single-use cartridge system.

The Idylla CDx MSI Test aids in identifying MSI-H colorectal cancer patients who may be eligible for treatment with OPDIVO (nivolumab) alone or in combination with YERVOY (ipilimumab), as established in the CheckMate-8HW clinical trial. Data from this trial reinforced the importance of accurate MSI-H and dMMR testing in guiding immunotherapy use.

The Idylla CDx MSI Test has received FDA Premarket Approval as the first cartridge-based, fully automated sample-to-result companion diagnostic for colorectal cancer. The FDA approval of the assay underscores its validation as a reliable companion diagnostic for precision oncology applications. This breakthrough allows oncologists to match patients more quickly with life-extending therapies, eliminating delays caused by conventional lab processes.

With FDA approval secured, the Idylla CDx MSI Test will soon be available across the US, with international availability expected to follow. By expanding access to automated, accurate MSI testing, the platform has the potential to improve global standards of cancer care and strengthen precision medicine strategies.

“Rapid and accurate diagnosis is crucial to enabling access to appropriate therapeutic approaches, and this latest advancement exemplifies our commitment to delivering innovative, targeted solutions that have the potential to improve outcomes for patients,” said Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb.

“Achieving FDA approval for our Idylla CDx MSI Test represents a key milestone for Biocartis,” said Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis. “It underscores our commitment to helping oncology patients receive the right therapy without delay and the recent CheckMate-8HW data reinforce the critical importance of accurate MSI-H/dMMR testing in colorectal cancer. With its speed, accuracy, and automation, the Idylla CDx MSI Test offers a powerful solution that enables clinicians to make timely, confident, and data-driven treatment decisions when every moment counts.”

Related Links:
Biocartis
Bristol Myers Squibb